GE PHOTON ENERGY RECOVERY (PER) OPTION

K023932 · Ge Medical Systems F.I. Haifa · KPS · Dec 11, 2002 · Radiology

Device Facts

• Record ID: K023932
• Device Name: GE PHOTON ENERGY RECOVERY (PER) OPTION
• Applicant: Ge Medical Systems F.I. Haifa
• Product Code: KPS · Radiology
• Decision Date: Dec 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

The Photon Energy Recovery (PER) Option is intended for image quality and quantification improvement by scatter reduction in planar and tomographic nuclear medicine images. This option enables Gated SPECT acquisition in multi-energy window format which allows normal GSPECT processing along with PER scatter correction on the summed data. It can be used for acquisitions of single or multi-peak isotope as well as simultaneous multi-isotope images.

Device Story

GE Photon Energy Recovery (PER) Option is a software application for nuclear medicine imaging systems. It processes nuclear spectra data acquired from single or multi-peak isotopes; performs spectral deconvolution analysis using iterative recurrent linear regressions to reduce Compton scatter and cross-talk down scatter. The software enables gated SPECT acquisition in multi-energy window format; allows scatter correction on summed data. Used in clinical settings by nuclear medicine technologists/physicians to improve image contrast, spatial resolution, and quantification. Output is a corrected nuclear image, aiding clinicians in diagnostic decision-making.

Clinical Evidence

Bench and clinical data provided. Study compared PER-corrected simultaneous dual-isotope images to conventional single-isotope images. Results indicated similarity in image quality and quantification performance.

Technological Characteristics

Software-based application for nuclear medicine imaging systems. Utilizes spectral deconvolution analysis via iterative recurrent linear regressions. Operates on multi-energy window nuclear spectra. Compatible with planar, SPECT, and gated SPECT acquisition modes. No specific hardware materials or connectivity standards listed.

Indications for Use

Indicated for patients undergoing planar or tomographic nuclear medicine imaging, including single or multi-peak isotope and simultaneous multi-isotope studies, requiring scatter reduction for improved image quality and quantification.

Regulatory Classification

Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Predicate Devices

• GE Vision Nuclear Medicine Workstation (K012568)

Submission Summary (Full Text)

{0}------------------------------------------------

K023932

GE Medical Systems

# DEC 1 1 2002

#### 10. 510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807,87(h))

Device Name Proprietary Device Name:

GE Photon Energy Recovery (PER) Option

#### Establishment Name and Registration Number of Submitter

| Name: | ELGEMS Ltd. |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number: | 9613299 |
| Corresponding Official: | Hemy Neuman, Quality and Regulatory<br>ELGEMS Ltd.<br>4 Hayozma St.<br>P.O. Box 170<br>Tirat Hacarmel 30200<br>ISRAEL<br>[e-mail]<br>[phone] fax<br>[phone] phone |

Device Classification Classification Code: Panel Identification: Classification Name:

90 KPS Radiology System, Emission Computed Tomography (per 21CFR 892.1200) Nuclear Medicine Imaging system Class II Product

Common Name: Classification Class:

Reason for 510(k) Submission Modification of legally marketed device.

Identification of Legally Marketed Equivalent Devices GE Vision Nuclear Medicine Workstation - K012568

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows a symbol that represents the zodiac sign Capricorn. The symbol is drawn with small dots, giving it a textured appearance. The Capricorn symbol is a mythical creature with the head and forelegs of a goat and the tail of a fish.

#### 510(k) Summary of Safety and Effectiveness, GE PER Option, Page 2

#### Device Description

The Photon Energy Recovery (PER) option is a software application for reducing the Compton scatter contribution in nuclear images. This enables scatter correction of single as well as multipeak isotope imaging. In addition it allows for the correction of cross-talk down scatter in simultaneous multiisotope imaging. The method is based on a spectral deconvolution analysis using iterative recurrent linear regressions on nuclear spectra. These spectra are broken down into multiple energy windows. This submission provides an extension on the PER features of the currently legally marketed device, GE Vision Nuclear Medicine Workstation - K012568.

#### Description of Change or Modification

The original PER application featured in the predicate device. GE Vision Nuclear Medicine Workstation (K012568), focuses on Compton scatter reduction for improved contrast and better spatial resolution. The new PER application extends this capability for nuclear cameras by enabling gated SPECT acquisition in multi-energy window format, allowing normal GSPECT processing along with PER scatter correction on the summed data.

The following features are included in the PER Option:

- Scatter correction for single isotope Static, SPECT, and . Gated scans
- . Scatter and cross-talk correction for simultaneous dual and multi-isotope imaging

#### Intended Use of Device

The Photon Energy Recovery (PER) Option is intended for image quality and quantification improvement by scatter reduction in planar and tomographic nuclear medicine images. This option enables Gated SPECT acquisition in multi-energy window format which allows normal GSPECT processing along with PER scatter correction on the summed data. It can be used for acquisitions of single or multi-peak isotope as well as simultaneous multi-isotope images.

{2}------------------------------------------------

# Summary of Studies

Bench and clinical data show that the PER corrected simultaneous dualisotope images are similar to the conventional single isotope images.

#### Conclusion

In the opinion of ELGEMS Ltd., the Photon Energy Recovery (PER) Option is substantially equivalent in terms of safety and effectiveness to the PER capabilities featured in the legally marketed GE Vision Nuclear Medicine Workstation (K012568).

{3}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

#### Public Health Service

9200 Corporate Boulevard Rockville MD 20850

ELGEMS. Ltd. % Mr. Jeff D. Rongero Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, NC 27709-3995

#### Re: K023932

. Trade/Device Name: GE Photon Energy Recovery (PER) Option . Regulation Number: 21 CFR 892:1200. Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 85 KPS Dated: November 25, 2002 Received: November 26, 2002

#### Dear Mr. Rongero:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

This letter will allow you to begin marketing your device as described in your 510(k) premarket. notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Henry C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## STATEMENT OF INTENDED USE

510(k) Number (if known):

K023932

Device Name: GE Quasar System

#### Indications for Use

The Photon Energy Recovery (PER) Option is intended for image quality and quantification improvement by scatter reduction in planar and tomographic nuclear medicine images. This option enables Gated SPECT acquisition in multi-energy window format which allows normal GSPECT processing along with PER scatter correction on the summed data. It can be used for acquisitions of single or multi-peak isotope as well as simultaneous multi-isotope images.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801-109)

OR Over-The-Counter Use

David A. Lynn

Reproductive, Abdominal,